Lung volume-reducing elastic implant and instrument

ABSTRACT

A lung volume-reducing elastic implant ( 2 ) and a lung volume-reducing instrument; the lung volume-reducing elastic implant ( 2 ) is tubular and comprises a proximal implant end ( 201 ), an elastic deformation part ( 205 ) and a distal implant end ( 202 ); the elastic deformation part ( 205 ) is located between the proximal implant end ( 201 ) and the distal implant end ( 202 ), and the elastic deformation part ( 205 ) has a shape memory characteristic; the lung volume-reducing elastic implant ( 2 ) is opened at the proximal implant end ( 201 ); the elastic deformation part ( 205 ) is provided with a plurality of grooves ( 204 ) at intervals along the longitudinal direction thereof; each groove ( 204 ) communicates with the tube cavity of the elastic deformation part ( 205 ); the lung volume-reducing instrument comprises the lung volume-reducing elastic implant ( 2 ) and a delivery device ( 1 ) matching same; the delivery device ( 1 ) comprises a guidewire ( 101 ) and a hollow push piece ( 110 ); the lung volume-reducing elastic implant ( 2 ) is detachably connected to the distal end of the hollow push piece ( 110 ) via the proximal implant end ( 201 ); and the guidewire ( 101 ) passes through the tube cavity of the lung volume-reducing elastic implant ( 2 ) and the tube cavity of the hollow push piece ( 110 ). The lung volume-reducing instrument is more convenient for an operation and takes shorter time, and avoids damage to the inner wall of the bronchia, reducing the occurrence of pneumothorax.

TECHNICAL FIELD

The present invention belongs to the technical field of interventionaltherapy, and relates to an implant and instrument for interventionaltherapy, in particular to a lung volume-reducing elastic implant and aninstrument.

BACKGROUND ART

In clinical treatment, emphysema is a common pulmonary disease,particularly having a high incidence in the elderly. According tostatistics, the survival rate of end-stage emphysema patients who havebeen sick for 5 years is less than 50 percent. Traditional emphysemamedical treatment comprises oxygen inhalation, prevention of pulmonaryinfection, bronchia spasmolysis, etc. but curative effect is extremelylimited. While the surgical treatment of emphysema is given priority tolung volume-reducing surgery, and there are also relatively largeamounts of limitations, such as strict indications accompanied withrelatively large amounts of complications, anesthesia and complicationsassociated therewith, the curative effect is difficult to predict beforesurgery, any undesirable curative effect caused by too much or toolittle removal cannot be compensated after surgery, and the operativecost is high, and mental and physical pain is significant. Additionally,some patients with poor lung function often cannot tolerate thesurgeries, therefore possessing high postoperative mortality, whichlimits the application of surgery.

In order to better treat emphysema, treatment for emphysema is carriedout in the intervening modes with bronchoscope researched and utilizedinternationally, such as a unidirectional valve, xanthan gum, watervapor thermal ablation, and elastic coil for improving the quality oflife for patients, and reducing the trauma to patients during surgery.Owing to the fact that the target area residual gas and sputum fails tobe discharged effectively and actively, a unidirectional valve has poorclinical index, so the U.S. FDA has not approved this device.Additionally, the effectiveness of unidirectional valve treatment isfurther restricted by the technical difficulty of collateral ventilationand accurate positioning on different anatomical structures. The problemof postoperative inflammation has also not been adequately solved, dueto the fact that the emphysema area is completely blocked by the xanthangum. In addition, the water vapor is subjected to thermal ablation,which causes postoperative inflammation because of its damage to theoriginal tissue structure of the emphysema area.

Currently, an updated treatment mode is adopted for the treatment ofemphysema, that is to say, the elastic coil, as an implant, is implantedinto the body pulmonary lesion site. FIG. 1 is a schematic diagram of alung volume-reducing elastic coil of the prior art. The product is madeup of nickel-titanium memory alloy metal wire for design, which can besubjected to elastic deformation under external force. The product,under the constraint of a delivery system, can be implanted into thelung with the bronchoscope working channel in the form of straightstrips. After being delivered to the bronchia in the emphysema area, thecoil is free from the constraints of the delivery system, recovering itsshape to its natural shape (i.e. the shape being free from the externalforce) as shown in FIG. 1. Meanwhile, the emphysema area is extrudedunder the traction action of the nickel-titanium alloy wire, the gas inthe bronchia is discharged, and the lung tissue volume in the emphysemaarea is reduced, such that the relatively healthy peripheral lung tissuegives play to better physiological function.

The surgical methods using the elastic coil comprise three operationalprocesses of inserting the bronchoscope, establishing the channel, andimplanting the coil. A schematic diagram showing the insertion of thebronchoscope 201 is shown in FIG. 2. A bronchoscope 201 is insertedthrough the mouth or nose, and an image detected by the distal end 203of the bronchoscope is displayed on a monitor 204 via the bronchoscope201, thereby guiding the bronchoscope 201 to reach the human pulmonarybronchia 205.

FIG. 2 also shows the establishment of the channel. The outer diameterof a guidewire 206 is about 5Fr to about 7Fr, while the tube diameter ofa delivery sheath can be between about 5Fr and 9Fr. The guide wire 206is inserted through the inner cavity of a dilator 207 which extendsthrough the inner cavity of a delivery sheath 208, and the guidewire206, the dilator 207 and the delivery sheath 208 are assembled togetherto enter the bronchoscope 201 through a working channel 202 of thebronchoscope 201 and to enter the bronchia 205 through the distal end203 of the bronchoscope 201. A distal end 209 of the guidewire 206 isprovided with a length marker 210, which indicates the distance alongthe guidewire 206 from the distal end 209. A distal end 211 of thedelivery sheath 208 can be provided with a plurality of correspondingidentifiers 210 in the form of high contrast metal strips (includinggold, platinum, tantalum, iridium, tungsten and/or similar metal). Theguidewire 206 can be guided using a fluoroscopy system with a remoteimaging capture device 212, an ultrasonic imaging system, an MRI system,an X-ray computed tomography (CT) calculating system, or some otherremote imaging implants. As shown in FIG. 2, the images detected can bedisplayed on a monitor 213 by the remote imaging capture device 212, andthe track of the guidewire 206 or an imaging marker 210 can beidentified by the remote imaging capture device 212, therebyestablishing a channel.

After establishing the channel, the dilator 207 and the guidewire 206are withdrawn from the delivery sheath 208 towards the proximal end,thereby delivering a lung volume-reducing elastic coil 301 in an opencavity of the delivery sheath 208. FIG. 3 is a schematic diagram showingthe implanting of the coil 301. A delivery system 302 loaded with thecoil 301 is coupled to the proximal end of the delivery sheath 208 by alocking hub connection 303. As shown in FIG. 4, the coil 301 isintroduced to the delivering sheath tube, and the coil 301 is pushed outof the distal end of the delivering sheath tube 208 by a wireline 305 ofan actuating device 304, thereby entering the bronchia 205. Thedelivering sheath tube 208 is then withdrawn, and the coil 301 isreleased by a gripper 306 of the actuating device 304. The coil 301further pulls the bronchia 205 to curl while the coil 301 recovers intoits original shape, thereby achieving the curative effect of reducingthe volume of emphysema.

The above implants and the implanting methods thereof have the followingshortcomings:

1. The elastic coil made from the prior nickel-titanium wire needs to bereleased by the delivery sheath, and the inner wall of the bronchiamight be injured when the delivery sheath is pushed in the bronchia,causing adverse effects such as pneumothorax.

2. Owing to relatively large outer diameter of the delivery sheath ofabout 5Fr to 9Fr, it is difficult to implant the elastic coil into thetail end of the lung bypass or each of some small-diameter tracheae viathe delivery sheath, and the range of emphysema area pressed and pushedby the elastic coil is limited, thereby affecting the volume-reductioneffect.

3. The present surgical method of inserting the elastic coil requiresthree independently operated processes of inserting the bronchoscope,establishing the channel, and implanting the coils, which takes a longtime to complete the procedure. In addition, the procedure is performedwhen the patient is sober, easily causing adverse events such as COPDacute exacerbation and the like due to the extended procedure time.

SUMMARY OF THE INVENTION

The technical problem to be solved by the present invention is toprovide an implant directly delivered by using a guidewire instead of adelivery sheath in order to overcome the aforesaid shortcomings in theprior art. By using the implant, injury to the inner wall of thebronchia by the delivery sheath can be avoided, and the occurrence rateof pneumothorax is reduced.

The technical problem to be further solved by the present invention isto provide a lung volume-reducing instrument capable of being implantedat the tail end of a lung bypass or each of some small-diameter tracheaeaccording to actual requirements, where the channel establishing processand the implant implanting operation process can be combined, so thatthe operation process is more convenient, the operation time is reduced,and a better treatment effect is achieved.

A lung volume-reducing elastic implant which is tubular and comprises aproximal end, an elastic deformation part and a distalt end, the elasticdeformation part is located between the proximal end and the distal endand at least the elastic deformation has a shape memory characteristic,at least the proximal end of the lung volume-reducing elastic implant isopened, the elastic deformation part is provided with a plurality ofgrooves at intervals along the longitudinal direction thereof, and eachgroove communicates with a tube cavity of the elastic deformation part.

In one embodiment of the technical scheme, included angles α formed bythe cut directions of the grooves and the length direction of theelastic deformation part are 10-90° on the axially split spreading planeof the lung volume-reducing elastic implant; and the shapes andarrangement of the grooves satisfy multidirectional bending and twistingof the elastic deformation part and meet the bending stress requirementof the implant.

In one embodiment of the technical scheme, the implant also comprises anelastic membrane coating the outer wall of the elastic deformation part.

In one embodiment of the technical scheme, the elastic membrane can alsocoat the surface of the whole implant and fills the grooves.

In one embodiment of the technical scheme, the outer diameter of theimplant is gradually increased from the distal end to the proximal end.

In one embodiment of the technical scheme, the proximal end of theimplant and the proximal end of the elastic deformation part form anintegrated structure.

In one embodiment of the technical scheme, the distal end of the implantextends outward to be connected with a flexible implant guide head, theimplant guide head is coaxial with the distal end of the implant andcloses the distal end of the implant, and the implant guide head isprovided with a developing identifier.

In one embodiment of the technical scheme, the proximal end of theimplant is provided with a detachable connecting piece in the lungvolume-reducing elastic implant.

A technical scheme adopted by the present invention also provides a lungvolume-reducing instrument comprising any one of the above implants, anda conveying, device matched with the implant, wherein the conveyingdevice comprises a guidewire and a hollow push piece, the implant isdetachably connected to the distal end of the hollow push piece via theproximal implant end, and the guidewire movably passes through the tubecavity of the implant and the tube cavity of the hollow push piece.

In one embodiment of the technical scheme, the distal end of theguidewire is provided with a flexible guidewire guide head coaxial withthe guidewire, and the guidewire guide head has an outer diameterconsistent with that of the guidewire.

In one embodiment of the technical scheme, the flexible guidewire guidehead can be provided with a developing identifier.

In one embodiment of the technical scheme, the flexible guidewire guidehead comprises a guide post, and a spring fixed and sleeved outside theguide post, and the guide post and the guidewire are integrallystructured or the guide post is fixedly connected to the distal end ofthe guidewire, and the spring has a developing identifier.

Compared with the prior art, the implant provided by the presentinvention is tubular and is opened at least at the proximal end toensure that the guidewire can be directly penetrated into the tubecavity of the implant to restrain the implant to form straight strips tobe delivered, so that the implant does not need to be restrained by thedelivery sheath with the outer diameter larger than that of the implant,so that the injury of the delivery sheath to the tracheae in thedelivery process is avoided, and the occurrence rate of pneumothorax isfurther reduced. On the other hand, the implant can be opened at boththe proximal end and the distal end or only opened at the proximal end.When the implant is opened at both the proximal end and the distal end,the guidewire can be utilized to directly guide in the trachea andestablish the channel. When the implant is only opened at the proximalend, the implant can comprise the flexible guide head arranged at thedistal end of the implant and used for closing the distal end of theimplant, at this moment, the flexible guide head can be utilized todirectly guide in the trachea and establish the channel by way ofinserting the guidewire into the tube cavity of the implant andrestraining the flexible guide head. Through loading and releasing byusing the guidewire, the implant can be implanted to the tail end of thelung bypass or each of some small-diameter tracheae to extrude anemphysema area so that the lung interventional curative effect isachieved.

The implant of the present invention has a hollow tubular cavitystructure, which facilitates the pre-threading of the guidewire througha tubular cavity of the implant during operation, so that the implant isloaded onto the guidewire, the implant and the guidewire arecollectively pushed into the bronchia of an emphysema area by virtue ofa bronchoscope, as described above, and the guidewire or the implant isused to establish a channel. After the implant is pushed to anappropriate target area, the guidewire is withdrawn to release theimplant, so that two operation processes (i.e. a channel establishingprocess and an implantation process) of the implant in the prior art aresynchronously completed, and the operation time can be effectivelyreduced, thereby avoiding adverse events such as COPD acute exacerbationand the like.

Moreover, the elastic deformation part of the implant or the wholeimplant is coated with an elastic membrane, so that a metal surface ofthe implant can be prevented from directly contacting an inner wall ofthe bronchia, and the release of metal elements is reduced, therebyeffectively reducing pneumonia or small airway infection.

An instrument of the present invention utilizes the guidewire to loadthe implant, as well as guides and establishes the channel, to deliverthe implant and to release the implant; or the implant distal end isprovided with a soft implant guide head, the implant guide head may playa role in guiding and establishing the channel, and the implant can beimmediately released after the channel is established; and the channelestablishing process and the implantation operation process of theimplant are combined by utilizing the solution, so that the operation ismore convenient, and the operation time can also be reduced.

In the instrument of the present invention, a conveying device uses theguidewire to pass through the implant with the tubular cavity structure,the implant is delivered by virtue of the pushing of a push mechanism,by means of the constraint of the guidewire, the implant is transitionedfrom a natural state (i.e. a predetermined curly state obtained afterthe heat treatment) to a delivery state (i.e. a straight strip shapematched with the shape of the guidewire). After the guidewire iswithdrawn from the tubular cavity of the implant, the constraint of theguidewire is released, and the implant can be transitioned from thedelivery state to the natural state, thereby achieving an effect ofextruding an emphysema target area. Compared with the prior art whichuses a delivery sheath, the diameter of the conveying device is smaller,so that the implant can enter a smaller emphysema target area, and abetter curative effect can be achieved. By adopting a technical solutioncombining the establishment of the channel and the release of theimplant, the present invention can shorten the whole operation time, andcan be more precisely positioned in the emphysema target area.

The instrument of the present invention also adopts the elastic membraneto coat the surface of the implant, and the elastic membrane is madefrom a high molecular material with better biological compatibility, sothat the elastic membrane of the high molecular material contacts theinner wall of the bronchia, compared with the solution adopting anickel-titanium wire to directly contact the inner wall of the bronchiain the prior art. Thus, the inflammation and injury of the bronchiacaused by the friction between the implant and the inner wall of thebronchia in the breathing process can be reduced, thereby reducing therisk of pneumonia and small airway infection. Additionally, the metalsurface of the implant is coated with the elastic membrane of the highmolecular material, thereby effectively reducing the release of themetal elements.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described below with reference to thedrawings and embodiments, and in the drawings:

FIG. 1 is a structural schematic diagram of an elastic coil in the priorart;

FIG. 2 is a schematic diagram showing the implantation of a bronchoscopeand the establishment of a channel by a guidewire in the prior art;

FIG. 3 is a schematic diagram showing the delivery of an elastic coil inthe prior art;

FIG. 4 is a schematic diagram showing the release of an elastic coil inthe prior art;

FIG. 5 is a structural schematic diagram of an implant provided by anembodiment of the present invention;

FIG. 6 is a sectional view of the implant as shown in FIG. 5;

FIG. 7 is a schematic diagram of a groove after the implant provided inone embodiment of the present invention is dissected and unfolded alonga longitudinal direction;

FIG. 8 is a schematic diagram of a groove after an elastic deformationpart of the implant provided in another embodiment of the presentinvention is constrained into a straight strip;

FIG. 9 is a local sectional view of the implant as shown in FIG. 8;

FIG. 10 is an expanded view of an implementation method of a groove ofan implant provided in another embodiment of the present invention;

FIG. 11 is a local schematic diagram of an elastic deformation part ofthe implant shown in FIG. 10;

FIG. 12 is an expanded view of another implementation method of a grooveof an implant provided in a further embodiment of the present invention;

FIG. 13 is a local schematic diagram of an elastic deformation part ofthe implant shown in FIG. 12;

FIG. 14 is a structural schematic diagram of an implant with aconnecting piece and a skeleton guide head provided in an embodiment ofthe present invention;

FIG. 15 is a structural schematic diagram of an implant reserving alocal elastic membrane provided in an embodiment of the presentinvention;

FIG. 16 is a schematic diagram of a lung volume-reducing instrumentprovided in an embodiment of the present invention;

FIG. 17 is an enlarged view of the position 1 in FIG. 16;

FIG. 18 is a schematic diagram showing the establishment of a workingchannel by a lung volume-reducing instrument provided in an embodimentof the present invention;

FIG. 19 is an enlarged view of the area A of FIG. 18;

FIG. 20 is a schematic diagram showing the implantation of an implantprovided in an embodiment of the present invention; and

FIG. 21 is an enlarged view of the area B of FIG. 20.

DETAILED DESCRIPTION OF THE INVENTION

In order to more clearly understand technical features, objectives andeffects of the present invention, the embodiments of the presentinvention are described in detail with reference to the drawings.

As shown in FIG. 5 and FIG. 6, an embodiment of the present inventionprovides a lung volume-reducing elastic implant, wherein the implant 2is in a tubular shape and comprises an implant proximal end 201, anelastic deformation part 205 and an implant distal end 202. The elasticdeformation part 205 is disposed between the implant proximal end 201and the implant distal end 202, and the elastic deformation part 205 atleast has a shape memory characteristic. The implant proximal end 201 inthe implant 2 is opened (the proximal end refers to the end closest to asurgical operator), and the three main parts of the implant 2 can be anintegrated structure in one piece, and can also be separate piecesfixedly connected with one another.

The elastic deformation part 205 comprises a tube cavity or lumen 207.The elastic deformation part 205 is provided with a plurality of grooves204 in the axial direction. i.e. the longitudinal direction, and thegrooves 204 communicate with the tube cavity 207. The elasticdeformation part 205 is the main structure of the implant 2, is in apredetermined curved shape in its natural state (i.e. not subjected toany external force), can be constrained to form straight strips or anyother shapes under the effect of an external force, and can recover itspredetermined shape through bending and twisting after the externalforce is removed. The implant 2 can be made from a material often usedin the industry and having a shape memory characteristic; specificmaterials are not limited in the present invention, and any materialsuitable for use in the human body and having a shape memorycharacteristic can be used. In the embodiment, the implant 2 is madefrom nickel-titanium alloy, specifically a hollow nickel-titanium tube.Particularly, after certain grooves 204 are cut in a raw material forthe hollow nickel-titanium tube, the nickel-titanium tube is bent to bein a predetermined shape and then is subjected to heating treatment andshaping to obtain the implant 2.

The outer diameter and inner diameter of the implant 2 depend on itscharacteristics and the outer diameter of the guide wire. That is basedon the premise that sufficient elastic force is maintained for tractionof the lung tissues, the implant 2 is implanted into the tail end of thelung bypass or each of some small-diameter tracheae to achieve a bettercurative effect. In addition, the inner diameter of the implant 2 shouldbe greater than the outer diameter of the guide wire. In one embodiment,the outer diameter of the implant 2 is 0.5 to 2.5 mm, and the wallthickness can be 0.01 to 0.5 mm.

The implant 2 can be an equal-diameter tube with the outer diameter andthe inner diameter maintained constant from one end to the other end,and can also be a non-equal-diameter tube having a variation in theouter diameter and the inner diameter. The implant 2 can extend into thethinner bronchia, in other embodiments of the present invention, theimplant 2 can be a tapered tube of which the tube cavity 207 does notvary in diameter but the tube wall is gradually increased in thicknessfrom the distal end to the proximal end. In other words, the outerdiameter of the implant 2 is gradually increased from the distal end tothe proximal end. For example, the tapered tube with an inner diameterof 0.8 to 10 mm is selected, and the wall thickness of the tapered tubechanges from 0.01 mm at the distal implant end 202 to 0.2 mm at theproximal implant end 201.

Larger-curvature bending of the elastic deformation part 205 can beachieved through the existing grooves 204. Twisting at various differentangles of the elastic deformation part 205 can be achieved, andaccordingly complex predetermined shapes can be formed. In the presentinvention, the arrangement of the grooves 204 is not limited, thegrooves 204 are generally arranged in a variety of modes, such asparallel mode and spiral mode, viewed from the peripheral direction ofelastic deformation part 205. The grooves 204 can also be arrangedlocally and can also be wholly arranged in the peripheral direction ofthe elastic deformation part 205. The grooves 204 can be of a variety ofstructures, for example, the grooves 204 can be generally of long andnarrow structures. Axial included angles α formed by the grooves 204 andthe elastic deformation part 205 are 10 to 90° on the axially splitspreading plane of the elastic deformation part 205; i.e. the includedangles α formed by the opening directions of the grooves 204 and theelastic deformation part 205 are 10 to 90°. The arrangement of thegrooves 204 aims at better bending and twisting, unparalleled axes ofthe grooves 204, and the elastic deformation part 205 facilitatesbending of the elastic deformation part 205. As a result, with theincluded angles α being 10 to 90°, the bending of the elasticdeformation part 205 within the same plane is facilitated, and bendingand twisting can be simultaneously achieved at included angles α whichare smaller than 90° so that the elastic deformation part 205 can beformed within the range of 360 degrees. In other embodiments of thepresent invention, the axial included angles α formed by the grooves 204and the elastic deformation part 205 are preferably 45 to 90°. Theshapes, quantity, arrangement density and positions of the grooves 204should satisfy multidirectional bending and twisting of the elasticdeformation part 205, the arrangement positions, quantity, shapes andarrangement density of the grooves 204 should also meet the requirementfor exerting a bending stress extruding the lung tissue after theimplant 2 is implanted into the lung tissue. In other words, the implant2 is prevented from puncturing the bronchia when pulling the tissues inthe emphysema area in the shape recovering process. The grooves 204 canbe specifically formed according to actual calculation, so that when theimplant 2 is implanted into the lung, bronchial puncture caused byexcessive local stress is not created, and the injury caused by theimplant 2 to the human body due to injury or breakage caused by theexcessive stress is also avoided.

In the embodiment shown in FIGS. 7 and 8, the single groove 204 isdumbbell-shaped, and it can be seen from the axially split spreadingplane view of the elastic deformation part 205 shown in FIG. 7 that theaxial included angles α formed by the grooves 204 and the elasticdeformation part 205 are 90°. Multiple grooves 204 are continuouslyformed at equal intervals, and all the grooves 204 are parallel to eachother. The dumbbell-shaped grooves 204 can satisfy the bending andtwisting of the elastic deformation part 205. Intervals 208 of about0.05 to 0.5 mm exist between the grooves 204. The outer diameter of theelastic deformation part 205 is 0.5 to 1.5 mm, and the wall thickness is0.01-0.2 mm.

In another embodiment of the present invention shown in FIGS. 10 and 11,the elastic deformation part 205 is provided with multiple groups ofgrooves 204. After the elastic deformation part is split axially andspread flat, it can be seen that each group of grooves 204 includesthree grooves 204 a, 204 b and 204 c arranged in the peripheraldirection of the elastic deformation part 205, and two ends of each ofthe three grooves are mutually aligned in the peripheral direction. Thegrooves 204 a, 204 b and 204 c have a certain interval 209, and aninterval 208 is provided between every two adjacent groups of grooves204. The grooves 204 of the long and thin structures, the extendingdirections of these grooves 204 and the axis of the elastic deformationpart 205 form certain included angles α. The bending stress of the wholeelastic deformation part 205 can be adjusted by adjusting the number andthe intervals 209 of all groups of parallel grooves 204, the includedangles α formed by the grooves 204, and the axis of the elasticdeformation part 205 and the intervals 208 among all groups of parallelgrooves 204, to allow the elastic deformation part 205 to meet theclinical requirements. In other embodiments, the number of grooves ineach group of grooves 204 can be 2 to 6, the interval 209 between everytwo adjacent grooves 204 can be 0.05 to 1 mm, the included angles α canbe 10 to 85°, and the interval 208 between every two adjacent groups is0.1 to 1.0 mm. The outer diameter of the elastic deformation part 205 is10 to 2.0 mm, and the wall thickness is 0.05 to 0.3 mm.

In another embodiment of the present invention shown in FIGS. 12 and 13,the middle section of the elastic deformation part 205 is divided intomultiple groups of prolated elliptoid grooves 204, and each group ofgrooves 204 consists of more than two side-by-side elliptoid grooves204. In the embodiment, each group of grooves 204 consists of thegrooves 204 a and 204 b which are arranged in an iterated mode, acertain interval 209 is provided between the grooves 204 a and 204 b,the included angles α formed by the grooves 204 and the axis of theelastic deformation part 205 are 90°, and the extending direction inwhich the groups are arranged and the axis of the elastic deformationpart 205 form a certain included angle β. The included angle β can be 60to 90°, intervals 208 of 0.3 to 5 mm are provided among the groups ofgrooves 204, and the groups of grooves 204 are periodically arranged ina stepped mode. For example, 5 to 20 groups of grooves 204 can form aperiod, and the grooves 204 periodically arranged in the stepped modefacilitates formation of the specific shape of the elastic deformationpart 205 through bending. The proximal implant end 201 and the distalimplant end 202, which are about 1.5 to 10 mm long, are arranged at twoends of the elastic deformation part 205, and a section of about 0.5 to5 mm long of the proximal implant end 201 is cut into a threaded grooveto serve as a connecting piece 210. The cut implant 2 is then bent to bein the shape shown in FIG. 14 by using a mold, and the implant 2 isformed through heat treatment and shaping. In the embodiment, the outerdiameter of the implant 2 is 12 to 2.5 mm, and the wall thickness is 0.1to 0.4 mm.

As shown in FIGS. 5 and 14, the proximal implant end 201 and the distalimplant end 202 are respectively arranged at two ends of the elasticdeformation part 205, wherein the proximal implant end 201 is used forarranging the connecting piece 210, and the distal implant end 202 isused for entering the bronchia in advance. The proximal implant end 201is connected with the connecting piece 210 for use in detachablyconnecting with a push mechanism (such as the hollow push steel cable).In the present invention, the detachable connection mode refers to theconnecting piece 210 being fixed to the push mechanism together beforepushing and during pushing, and the connecting piece 210 breaks awayfrom the push mechanism after the implant 2 is positioned at the desiredlocation. There are a variety of structures detachably connected withthe connecting piece 210 and a variety of connection modes. As shown inFIG. 5, the threaded connection is adopted, and the connecting piece 210with inner thread is welded at the proximal implant end 201. Duringassembly, the connecting piece 210 can be in threaded connection with apush mechanism having an outer thread; after a corresponding position isreached through pushing, the connecting piece 210 can be separated fromthe push mechanism by twisting the push mechanism. Obviously, based onthe prior art, the connecting piece 210 can be made of other detachableparts, such as a magnetic connecting device, an elastic fastener, and alasso, which are respectively arranged at the proximal implant end 201of the implant 2 and the push mechanism to achieve the detachableconnection. Alternatively inner threads can be directly lathed on to theproximal implant end 201 to serve as the connecting piece 210 (namely,the proximal implant end 201 can be a part of the elastic deformationpart 205). As shown in FIG. 14, the connecting piece 210 arranged at theproximal implant end 201 is of a spiral connecting hook, similarly, aspiral connecting hook is also arranged on the push mechanism, and theyare mutually and rotatable hooked together so that the implant 2 can bedetachably and fixedly connected at the distal end of the pushmechanism.

As shown in FIG. 14, for enabling the implant 2 to smoothly enter thetrachea, the distal implant end 202 is extended outwardly to beconnected with a flexible implant guide head 211 when the distal end ofthe implant 2 is not opened, wherein the implant guide head 211 iscoaxial with the distal implant end 202 and closes the distal implantend 202, and the implant guide head 211 is provided with a developingidentifier. The implant guide head 211 provides guidance and establishesa channel, and can form an integral structure with the distal implantend 202 and can also be additionally fixed to the distal implant end202. The implant guide head 211 has relative flexibility to avoidscratching the tracheal wall after entering the trachea. The developingidentifier is configured to facilitate monitoring in the pushing processand can allow the implant 2 to be displayed through a fluoroscopysystem, an ultrasonic imaging system, an MRI system, a computed X-raytomography (CT) system or other remote imaging systems, among others.The implant 2 is displayed and guided through these systems, and in theembodiment, a spring, which is 1 to 10 mm long and is formed by windingtungsten, tantalum and other metal wires with the diameters of 0.1 to0.5 mm and having strong X-ray developing characteristic, serves as thedeveloping identifier. In the embodiment, the developing identifier andthe implant guide head 211 are integrated into one part to achieve twofunctions. Except the mode, a developing identifier can also beadditionally arranged on the implant guide head 211, for example adeveloping ring can be used where the implant guide head 211 is sleevedwith the developing ring.

As shown in FIGS. 6 and 9, in the above embodiments, the elasticdeformation part 205 can further be externally coated with an elasticmembrane 206. In one embodiment, the elastic membrane 206 coats each ofthe elastic deformation part 205, the proximal implant end 201 and thedistal implant end 202, so that the bronchia is not damaged in theimplanting process of the whole implant 2. The grooves 204 can be filledwith the elastic membrane 206 to ensure that the overall surface of theimplant 2 is smooth, and the grooves 204 are filled with the elasticmembrane 206 so that the elastic membrane 206 can firmly coat thesurface of the implant 2. Meanwhile, for ensuring smoothness in the tubecavity 207 of the elastic deformation part 205, the inner wall formed bythe elastic membrane 206 in the grooves 204 is aligned with the innerwall of the tube cavity 207 of the elastic deformation part 205. Thethickness of the elastic membrane 206 can be 0.01 to 0.3 mm. The elasticmembrane 206 can be made from high-molecular materials having excellentchemical stability, water-proofing, and weather-aging resistance, goodlow compressibility, good biocompatibility, high mechanical strength,non-toxicity, and can be odorless, among other characteristics. Forexample, these high-molecular materials can be silicone rubber orpolyurethane materials. When the implant guide head 211 is provided, theelastic membrane 206 coats the elastic deformation part 205 and theimplant guide head 211 thereof simultaneously to form the elasticmembrane 206 with an integrated structure.

FIG. 15 is a sectional view of the implant 2 with the local elasticmembrane 206 provided by one embodiment of the present invention, andthe deformation part of the elastic deformation part 205 includingmultiple groups of grooves 204. The surfaces of the elastic deformationpart 205, the proximal implant end 201, the distal implant end 202 andthe implant guide head 211 are coated with a layer of elastic membrane206.

It is worth mentioning that the two ends of the lung volume-reducing,elastic implant 2 of one embodiment of the invention are opened, namelyboth the proximal implant end 201 and the distal implant end 202 areopen, and it is possible for the implant 2 to not include the implantguide head 211.

One embodiment of the invention further provides a lung volume-reducing,instrument, as shown in FIGS. 1 to 21, which comprises the implant 2 anda delivery device 1, wherein the implant 2 is of a tubular structurehaving a shape memory characteristic, the body of the implant 2 is theelastic deformation part 205, and the elastic deformation part 205 isprovided with a tube cavity 207. The two ends of the implant 2 are theproximal implant end 201 and the distal implant end 202, a plurality ofgrooves 204 are formed in the surface of the elastic deformation part205 and extend through the tube cavity 207 of the elastic deformationpart 205. The deliver device 1 comprises a guide wire 101 and a pushmechanism 110 (generally, the push mechanism 110 comprises a hollow pushpiece, namely a hollow steel cable 103, and a control handle 106connected with the hollow steel cable 103). The implant 2 is detachablyconnected to the distal end of the push mechanism 110 through theconnecting piece 210, the guide wire 101 extends through a lumen of theimplant and the hollow steel cable 103 respectively. In other words, theguide wire 101 is loaded in the implant 2 and the hollow steel cable103, and the implant 2 can move along the guide wire 101.

In the delivery device 1, the guide wire 101 is used for holding andguiding implant 2, and establishing a channel. The implant 2 enclosesthe guide wire 101, and the implant 2 is constrained to be in a straightstrip shape by the guide wire 101. In other words, the implant 2 isstretched by the guide wire 101 to be in a straight delivery state thatis aligned with the shape of the guide wire 101 to facilitate access tothe bronchia.

Referring to FIG. 16, the guide wire 101 can be inserted into theproximal implant end 201 of the implant 2, and the guide wire 101 can bemade of a metal wire with the diameter of 0.1 to 1.1 mm. The guide wire101 has the roles of establishing the channel and delivering the implant2 to a diseased part, accordingly a sheath is no longer needed forconstraining the implant 2, so that injury caused by a sheath to thebronchia is also avoided, and the occurrence rate of pneumothorax isfurther reduced. The metal wire has a certain rigidity and toughness,can be properly bent, fits with the shape of the bronchia, and canadvance step by step along the trachea. Compared with the prior art, dueto the fact that a sheath is no longer needed in the delivery process,the implant 2 can be implanted into the tail end of the lung bypass oreach of some small-diameter tracheae to achieve a good curative effect.

For achieving safe and convenient operation, a soft guide wire guidehead 102 coaxial with the guide wire 101 and provided with a developingidentifier is arranged at the distal end of the guide wire 101, with theguide wire guide head 102 consistent with the guide wire 101 in outerdiameter. As shown in FIG. 17, the guide wire guide head 102 comprises aguide post 102 a and a spring 102 b fixed and sheathed outside of theguide post 102 a, and the guide post 102 a forms an integral structurewith the guide wire 101 or is fixedly connected to the distal end of theguide wire 101. The spring 102 b can have a developing identifier.

The guide wire guide head 102 can effectively avoid injury to thetracheal wall during implantation into the trachea because of thesoftening of the distal end of the guide wire 101. The soft guide wireguide head 102 can be achieved through the spring that has a softcharacteristic; i.e. the guide post 102 a forming the integral structurewith the guide wire 101 or fixedly connected to the distal end of theguide wire 101 is sheathed with the spring 102 b. The specificmanufacturing process is that the head end of the guide wire 101 isthinned and then is manufactured into the guide post 102 a, and then thespring 102 b with the length of 5 to 150 mm is fixed to the outside ofthe guide post 102 a. The fixing mode of the spring 102 b and the guidewire 101 can be macromolecular heat shrinkable tube or film coating,adhesive bonding, laser welding, tin soldering and on the like. Underthe guidance of the soft guide wire guide head 102, the guide wire 101can smoothly enter the tube cavity 207 of the elastic deformation part205 from the proximal implant end 201 of the implant 2, and the implant2 can be constrained from the shape shown in FIGS. 5 and 6 into thestraight delivery state, as shown in FIG. 16. Based on the prior art,the guide wire 101 loaded with the implant 2 also controls guidance andestablishes the channel in the bronchia. Because the guide wire 101entering the lung needs to be guided and monitored, the developingidentifier therefore is arranged on the guide wire guide head 102. Thedeveloping identifier can display the implant through a fluoroscopysystem, an ultrasonic imaging system, an MRI system, a computed X-raytomography (CT) system or other remote imaging systems, among othersimilar systems. The guide wire 101 is displayed and guided throughthese systems, and in the embodiment, the spring formed by windingtungsten, tantalum and other metal wires with the diameters of 0.01 to0.3 mm and having strong X-ray developing characteristic serves as thedeveloping identifier. In the embodiment, the developing identifier andthe guide wire guide head 102 are integrated into one part to achievetwo functions. Except such mode, a developing identifier can be furtherarranged on the guide wire guide head 102. Certainly, when the implantsurface of the present invention is not coated with the elastic membraneand is made from a material capable of performing development itself,such as, nickel-titanium alloy, the developing identifier may be notincluded.

For facilitating delivery of the guide wire 101, a guide wire handle 105is arranged at the proximal end of the guide wire 101 and used forforward delivery of the guide wire 101, or for withdrawing the guidewire 101 after the implant 2 is delivered to the desired location.

Specifically, the push mechanism 110 comprises a hollow push steel cable103 and a control handle 106 connected with the push steel cable 103,the guide wire 101 is sleeved with the push steel cable 103 and theimplant 2, and the distal end of the push steel cable 103 is connectedwith a connecting piece 210 arranged at the proximal end of the implant2. The adopted connecting mode is a detachable connection achievedthrough the connecting piece 210 arranged on the implant 2 and aconnecting fitting piece 109 arranged at the distal end of the pushsteel cable 103. The connecting piece 210 and the connecting fittingpiece 109 can adopt a variety of structures and connecting modes, forexample, threaded connection. The connecting piece 210 with innerthreads can be welded at the proximal implant end 201 of the implant 2,or inner threads can be directly lathed onto the proximal implant end201 to serve as the connecting piece 210. The connecting fitting piece109 with outer threads arranged at the distal end of the push steelcable 103, the inner thread of the connecting piece 210 can be inthreaded connection with the outer thread of the push mechanism 110during assembly, and then the implant 2 can be reliably fixed to thedistal end of the push steel cable 103. After the implant 2 is pushed toreach a desired position, the connecting piece 210 of the implant 2 canbe screwed out to be separated from the connecting fitting piece 109 ofthe push steel cable 103 by twisting the control handle 106 of the pushsteel cable 103. The connecting piece 210 and the connecting fittingpiece 109 can also be made from other detachable parts, such as magneticconnecting devices, elastic fasteners and lassos, which are respectivelyarranged at the proximal implant end 201 of the implant 2 and the pushsteel cable 103 to achieve the detachable connection. As shown in FIG.16, the connecting piece 210 arranged at the proximal implant end 201 isof a spiral connecting hook, similarly, a spiral connecting hook is alsoarranged at the distal end of the push steel cable 103, so they can bemutually and rotatably hooked together so that the implant 2 can bedetachably and fixedly connected at the distal end of the push mechanism110. After the implant 2 is pushed in place, the control handle 106 ofthe push steel cable 103 is turned in reverse to separate the two spiralconnecting hooks.

During production and assembly, the assembly of the implant 2 and theguide wire 101 can be completed by means of a loader. First, the implant2 penetrates into the loader, the implant 2 curled in a natural statecan be constrained into a tube in a straight strip shaped delivery stateby utilizing the space limitation of the loader. The guide wire 101 isassembled by inserting the push mechanism 110 into the proximal implantend 201 of the implant 2 and penetrating out of the distal implant end202 of the implant 2 until a guide wire guide head 102 of the guide wire101 penetrates out of the distal implant end 202 of the implant 2. Or inthe circumstance that the distal implant end 202 is closed by an implantguide head 211, the guide wire 101 is inserted into the proximal implantend 201 of the implant 2 and mounted at the distal implant end 202 ofthe implant 2. The loader can be dismounted when the implant 2 is loadedto be in a straight delivery state under the constraint of the guidewire 101, and the connecting fitting piece 109 at the distal end of thepush steel cable 103 in the push mechanism 110 is connected with theconnecting piece 210 of the implant 2.

As shown in FIGS. 18 to 21, the guide wire 101 which penetrates into theimplant 2 in a sleeved mode is introduced into the bronchia 904 of thelung 903 through an operating channel 902 of a bronchoscope 901. Afterthe channel is established through the guide wire 101 under theassistance of X rays, the implant 2 is pushed to the guide wire guidehead 102 by utilizing the push steel cable 103 along the guide wire 101.Next, the guide wire 101 is withdrawn, and the implant 2 automaticallyrestores its shape from the straight strip shaped delivery state formeddue to the constraint of the guide wire 101 as shown in FIGS. 18 and 19to its natural shape as shown in FIGS. 20 and 21 while the guide wire101 is withdrawn. The emphysema area can be extruded and pulled in therestoration process, while the surrounding relatively-healthy lungtissues can also perform their physiological breathing functions,thereby achieving the lung volume-reducing effect. Then, the threadedconnection between the connecting fitting piece at the distal end of thepush steel cable 103 and the connecting piece 210 of the implant 2 canbe loosened by turning the control handle 106 of the push steel cable103, and the implant 2 is released.

The invention claimed is:
 1. An assembly comprising: a lungvolume-reducing elastic implant, characterized in that the implant istubular and comprises a lumen, a proximal end, an elastic deformationpart and a distal end, the elastic deformation part is located betweenthe proximal end and the distal end and has a tube cavity, the elasticdeformation part having a shape memory characteristic, the lungvolume-reducing elastic implant is opened at least at the proximal end,the elastic deformation part is provided with a plurality of grooves atintervals along the longitudinal direction thereof, and each groovecommunicates with the tube cavity of the elastic deformation part; and adelivery device comprising a guidewire and a hollow push piece that hasa distal end and a lumen, wherein the proximal end of the implant isdetachably connected to the distal end of the hollow push piece, and theguidewire movably extends through the entire lumens of the implant andthe hollow push piece.
 2. The assembly according to claim 1,characterized in that angles α formed by cut directions of the groovesand the longitudinal direction of the elastic deformation part are10-90° on the axially split spreading plane of the implant.
 3. Theassembly according to claim 2, characterized in that the implant furthercomprises an elastic membrane which at least coats the outer wall of theelastic deformation part.
 4. The assembly according to claim 3,characterized in that the grooves are filled with the elastic membrane.5. The assembly according to claim 1, characterized in that the implanthas an outer diameter that is gradually increased from the distal end tothe proximal end.
 6. The assembly according to claim 1, characterized inthat the distal end of the implant is extended outwardly to be connectedwith a flexible guide head, the guide head is coaxial with the distalend of the implant and closes the distal end of the implant, and theguide head is provided with a developing identifier.
 7. The assemblyaccording to claim 1, characterized in that a detachable connectingpiece is arranged at the proximal end of the implant.
 8. An assemblycomprising: a lung volume-reducing elastic implant, characterized inthat the implant is tubular and comprises a lumen, a proximal end, anelastic deformation part and a distal end, the elastic deformation partis located between the proximal end and the distal end and has a tubecavity, the elastic deformation part having a shape memorycharacteristic, the lung volume-reducing elastic implant is opened atleast at the proximal end, the elastic deformation part is provided witha plurality of grooves at intervals along the longitudinal directionthereof, and each groove communicates with the tube cavity of theelastic deformation part; and a delivery device comprising a guidewireand a hollow push piece that has a distal end and a lumen, wherein theproximal end of the implant is detachably connected to the distal end ofthe hollow push piece, and the guidewire movably extends through thelumens of the implant and the push piece; and wherein the distal end ofthe guidewire is provided with a soft guidewire guide head coaxial withthe guidewire, and the guidewire guide head has an outer diameterconsistent with that of the guidewire.
 9. The assembly of claim 8,characterized in that the guidewire guide head comprises a guide post,and a spring fixed and sleeved outside of the guide post, and the guidepost and the guidewire are integrally structured or the guide post isfixedly connected to the distal end of the guidewire, and wherein thespring has a developing identifier.
 10. The assembly according to claim1, characterized in that angles α formed by cut directions of thegrooves and the longitudinal direction of the elastic deformation partare 10-90° on the axially split spreading plane of the implant.
 11. Theassembly according to claim 10, characterized in that the implantfurther comprises an elastic membrane which at least coats the outerwall of the elastic deformation part.
 12. The assembly according toclaim 11, characterized in that the grooves are filled with the elasticmembrane.
 13. The assembly according to claim 8, characterized in thatthe implant has an outer diameter that is gradually increased from thedistal end to the proximal end.
 14. The assembly according to claim 8,characterized in that the distal end of the implant is extendedoutwardly to be connected with the guidewire guide head, the guide headbeing coaxial with the distal end of the implant and closes the distalend of the implant, and the guidewire guide head is provided with adeveloping identifier.
 15. The assembly according to claim 8,characterized in that a detachable connecting piece is arranged at theproximal end of the implant.